MISSISSAUGA, ON, Feb. 16, 2016 /CNW/ - Cipher Pharmaceuticals Inc. (NASDAQ: CPHR; TSX:CPH) ("Cipher" or "the Company") today announced that its New Drug Submission for Sitavig™ has been accepted for review by Health Canada. Sitavig (acyclovir mucoadhesive buccal tablets) is proposed for the treatment of recurrent herpes labialis (cold sores) in adults.

"Cold sores are one of the most common viral skin infections, affecting one in five Canadians," said Shawn O'Brien, President and CEO of Cipher. "In addition to the pain, this is a highly stigmatizing disorder. If approved, Sitavig will represent an attractive treatment option for the many Canadians who suffer from cold sores and another key addition to our growing Canadian dermatology portfolio."

In the United States, Sitavig® is approved as a single-dose prescription cold sore treatment. Based on proprietary Lauriad® technology from Onxeo S.A, Sitavig is a 50 mg mucoadhesive tablet, which the patient places inside the lip on the upper gum and, in clinical trials, has been seen to deliver acyclovir to the site of the cold sore infection.

"The Health Canada submission for Sitavig is a joint achievement for Cipher and Onxeo that reflects great collaboration and regulatory work by the two companies over the past several months," said Judith Greciet, CEO of Onxeo S.A. "Should Sitavig receive approval in Canada, it will strengthen the brand in North America and increase the availability of the product for patients suffering from cold sores."

Cipher acquired the North American distribution rights to Sitavig with the April 2015 acquisition of INNOCUTIS Holdings LLC, which originally licensed the product from Onxeo S.A. Cipher plans to market Sitavig through its Canadian sales force.

About Cipher Pharmaceuticals Inc.Cipher Pharmaceuticals (NASDAQ: CPHR; TSX:CPH) is a rapidly growing specialty pharmaceutical dermatology company with a diversified portfolio of commercial-stage products with the goal of becoming the most customer-centric dermatology company in North America.

Cipher completed seven transactions in 2015, including the acquisition of INNOCUTIS and its nine branded dermatology products, to build its U.S. commercial presence, expand its Canadian dermatology franchise and broaden its pipeline. Cipher is well-capitalized to drive long-term, sustained earnings growth by leveraging its proven clinical development capabilities and efficient commercial execution. For more information, visit www.cipherpharma.com.

About OnxeoOnxeo has the vision to become a global leader and pioneer in oncology, with a focus on orphan or rare cancers, through developing innovative therapeutic alternatives designed to "make the difference". The Onxeo team is determined to develop innovative medicines that provide patients with hope and significantly improve their lives.

Forward-Looking Statements

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